The U.S. Food and Drug Administration has sent a letter to Fresenius Medical Care Holdings Inc. warning the company that its facilities used to produce kidney dialysis devices are out of compliance with FDA standards. The FDA said the findings in the letter followed an inspection of the Waltham-based company’s plant between June 15 and August 6, 2010.
The letter, dated September 15, claims that Fresenius has not taken sufficient action to address a faulty product, called a Liberty Cassette, which is a disposable part for home dialysis machines. The FDA said that the company investigated 118 complaints between 2001 and 2009 that the devices leaked, causing six adverse patient reactions and two cases of peritonitis. While the company put a hold on shipping the devices, and ordered a rework of the device in November of 2009, it did not issue a recall, or take other action to reduce patient risk, for devices already on the market.